1.Clinical Efficacy and Safety of Qingyusan Capsules in Treatment of Ulcerative Colitis with Syndrome of Large Intestine Dampness-heat
Xiaowen LIU ; Sizhen GU ; Danbo DOU ; Shigui XUE ; Yini TANG ; Gan CAI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):114-121
ObjectiveTo evaluate the efficacy and safety of Qingyusan capsules in the long-term treatment of mild to moderate active ulcerative colitis (UC) with the syndrome of large intestine dampness-heat. MethodA randomized, controlled design was adopted, and 88 patients with mild to moderate UC and syndrome of large intestine dampness-heat were randomized into a Qingyusan (Qingyusan capsules, 0.8 g·d-1) group and a control (mesalazine, 0.4 g·d-1) group, with 44 patients in each group. Three and one patients dropped out in the control and Qingyusan groups, respectively, during the 32 weeks of treatment. The clinical remission rate, mucosal healing rate, and modified Mayo score, TCM symptom score, and short inflammatory bowel disease questionnaire (SIBDQ) score before and after treatment were compared between the two groups. The colonoscopic and pathological changes were observed, and the clinical safety was compared between the two groups. ResultAfter treatment, the clinical remission rate and mucosal healing rate in the Qingyusan group were 72.1% (31/43) and 74.4% (32/43), respectively, which were higher than those [26.8% (11/41) and 41.5% (17/41), respectively] in the control group (χ2=17.200, χ2=10.843, respectively, both P<0.01). The treatment in both groups decreased the modified Mayo score, partial Mayo score, and TCM symptom score (P<0.05), and the decreases in the Qingyusan group were higher than those in the control group (P<0.01). After treatment, the SIBDQ scores in both groups increased (P<0.05), and the increase was more pronounced in the Qingyusan group than in the control group (P<0.01). There was no difference in the incidence of adverse events between the two groups. ConclusionThe clinical efficacy of Qingyusan capsules is remarkable in the long-term treatment of UC with the syndrome of large intestine dampness-heat. Particularly, Qingyusan capsules demonstrates advantages in inducing and maintaining clinical remission, promoting mucosal healing, alleviating TCM symptoms, and enhancing the survival quality of patients, with high safety.
2.Effect of BU and CY versus TBI and CY as conditioning regimens on the efficacy of haploidentical stem cell transplantation in patients with hematologic malignancy.
Qun SHAO ; Dongmei HAN ; Danbo LIU ; Xiaoli ZHENG ; Lei DONG ; Zhidong WANG ; Li DING ; Hongmin YAN ; Hengxiang WANG ; Lianning DUAN
Chinese Journal of Hematology 2014;35(6):505-510
OBJECTIVETo investigate the therapeutic effects of the conditioning regimen with busulfan plus cyclophosphamide (BU+CY) or total body irradiation plus cyclophosphamide (TBI+CY) on haploidentical stem cell transplantation (HSCT) in hematologic malignancy.
METHODSThe clinical outcomes of 77 HSCT recipients with hematologic malignancy from January 2001 to December 2010, including 21 AML, 33 ALL, 19 CML and 4 MDS were retrospectively evaluated. Among them, 65 patients obtained complete remission (CR) and 12 non-remission (NR) before transplantation; 39 patients received conditioning regimen with BU+CY, and 38 with TBI+CY.
RESULTSThere were no statistically significant differences in hematopoietic reconstitution, disease free survival (DFS), and transplant- related mortality (TRM) between two groups. The estimated 3- years overall survival (OS) was 56.4% for BU+CY and 31.6% for TBI + CY (P=0.0283). The overall relapse rate was similar between two groups (15.4% vs 34.2%; P=0.1538). However, the accumulative probability of relapse at 1-year was significantly lower in BU+CY than that in TBI+CY group (2.56% vs 26.67%; P=0.0116). The incidence of grade II-IV graft-versus-host disease (GVHD) was similar between two regimens (20.5% in BU+CY group and 18.4% in TBI+CY group; P=0.8168). The incidence of chronic GVHD (cGVHD) was higher in the TBI+CY group than that of BU+CY group (84.6% vs 41.1%; P=0.0007). The extensive GVHD obtained the similar outcome (30.8% vs 10.5%; P=0.0416).
CONCLUSIONPatients using BU+CY as conditioning regimen before transplant could obtain a better 3 year OS and lower short-term relapse rate. The TBI+CY conditioning regimen could significantly increase the incidence of cGVHD without increasing the acute GVHD. BU+CY conditioning regimen could be used for HSCT, but the attention should be paid to prevent the related hemorrhagic cystitis.
Adolescent ; Adult ; Busulfan ; administration & dosage ; Child ; Child, Preschool ; Cyclophosphamide ; administration & dosage ; Female ; Hematologic Neoplasms ; therapy ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Transplantation Conditioning ; methods ; Whole-Body Irradiation ; Young Adult